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Procedures:
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* 2 screening visits to make sure you are eligible to be in the study. This will include a fasting blood draw and heart tracing (EKG).
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* If you are eligible, you will complete both exercise conditions in a random order. All participants in the study will complete the following separated by 3-4 weeks:
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* Baseline condition of NO exercise
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* Morning exercise for 3 days in a row
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* Evening exercise for 3 days in a row
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* You will be provided with an example diet to follow for the days you are completing the baseline and exercise conditions (three days total for each condition). This diet will be a "traditional" diet with a controlled amount of carbohydrates, protein, and fat per day. The investigators will provide you with examples of meals to eat during this time.
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* You will be asked questions and complete questionnaires about your health history, sleeping and awakening habits, and sleepiness levels.
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* You will undergo one x-ray scan to measure your level of body fat.
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* You will be asked to wear an activity monitor and sleep monitor for 6 days in a row three times during this study.
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* You will be asked to wear a continuous glucose monitor (CGM) for 6 days in a row three times during this study.
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* You will be asked to measure your saliva melatonin levels three times in the study. This will be done once per hour for 5 hours (a total of 6 saliva samples).
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* You will be asked to complete a procedure called a "hyperinsulinemic-euglycemic clamp" where you will have an IV placed and insulin and glucose infused with frequent lab and finger stick blood sugars monitored closely. This will be done 3 times during the study. conditions: PreDiabetes conditions: Obesity conditions: Inactivity/Low Levels of Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: AM Exercise name: PM Exercise measure: Peripheral insulin sensitivity measure: Free Living Glucose measure: Melatonin offset measure: AM Cortisol measure: Physical activity and sedentary behavior measure: Sleep outcomes sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Rebecca Rosenberg, DO role: CONTACT phone: 503-442-0762 email: rebecca.rosenberg@cuanschutz.edu name: Rebecca Rosenberg, DO role: PRINCIPAL_INVESTIGATOR name: Seth Creasy, PhD role: SUB_INVESTIGATOR name: Victoria Catenacci, MD role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06291987 id: IRB23-1681 briefTitle: Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation acronym: MPN overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2026-05 date: 2026-05 date: 2024-03-04 date: 2024-04-26 name: University of Chicago class: OTHER briefSummary: The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs. conditions: Myeloproliferative Neoplasms studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Ivosidenib name: Ruxolitinib measure: Maximum tolerated dose measure: Overall Survival (OS) measure: Overall Response Rate (ORR) measure: Time to Response (TTR) measure: Duration of response (DOR) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago Medicine Comprehensive Cancer Center city: Chicago state: Illinois zip: 60637 country: United States name: Clinical Trials Intake role: CONTACT phone: 855-702-8222 email: cancerclinicaltrials@bsd.uchicago.edu name: Anand Patel role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06291974 id: delta2024 briefTitle: Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-15 date: 2024-11-30 date: 2024-03-04 date: 2024-03-07 name: Delta University for Science and Technology class: OTHER briefSummary: To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III). conditions: Cerebral Palsy Spastic Diplegia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: electromyography measure: muscle activity by Electromyography device sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06291961 id: CS-101-01 briefTitle: A Safety and Efficacy Study Evaluating CS-101 in Subjects With β-Thalassemia Major overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-07 date: 2024-03-04 date: 2024-03-06 name: CorrectSequence Therapeutics Co., Ltd class: INDUSTRY briefSummary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating patients with β-thalassemia major anemia. conditions: Beta-Thalassemia Major studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: CS-101 injection measure: AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-101 infusion measure: Overall survival rate measure: Proportion of subjects with engraftment measure: Time to neutrophil engraftment measure: Time to platelet engraftment measure: Incidence of transplant-related mortality measure: Change in fetal hemoglobin(HbF) concentration over time measure: Change in total hemoglobin(Hb) concentration over time measure: Chimerism level in Peripheral blood and bone marrow measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months measure: Proportion of subjects achieving fetal hemoglobin(HbF) increase≥2.0 g/dL measure: Proportion of subjects achieving fetal hemoglobin(HbF) increase≥7.0 g/dL sex: ALL minimumAge: 7 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi country: China name: Yongrong Lai, M.D. role: CONTACT name: Yongrong Lai, M.D. role: PRINCIPAL_INVESTIGATOR lat: 22.81667 lon: 108.31667 facility: Children's Hospital of Fudan University city: Shanghai state: Shanghai country: China name: Xiaowen Zhai, M.D. role: CONTACT name: Xiaowen Zhai, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Ruijin Hospital Shanghai JiaoTong University School of Medicine city: Shanghai state: Shanghai country: China name: Saijuan Chen, M.D. role: CONTACT name: Saijuan Chen, M.D. role: PRINCIPAL_INVESTIGATOR name: Weili Zhao, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06291948 id: 0225 briefTitle: A Clinical Study With Adalimumab Biosimilar overallStatus: COMPLETED date: 2022-08-01 date: 2023-01-10 date: 2023-10-20 date: 2024-03-04 date: 2024-03-04 name: Laboratorios Richmond S.A.C.I.F. class: INDUSTRY name: FP Clinical Pharma S.R.L. name: Custom Biologics briefSummary: The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) \[Test Product\] vs. Humira® AC Pen \[Reference Product\] conditions: Pharmacokinetics conditions: Safety Issues studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Double Blind, Parallel groups, Phase 1 Clinical Study comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Study subjects, investigators, Sponsor, monitor, analytical center, and data analyst will be unaware of assigned treatments.
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Each product in its original primary packaging will be blinded and labeled with a fantasy name "Product A" or "Product B".
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The link between "Product A or B" with the Test Product or Reference Product will be kept in two separate copies in a sealed envelope. One copy will remain with the Sponsor and the other will be provided to the Principal Investigator. The envelope may only be opened in the event of a medical emergency. The investigator must follow the trial's randomization procedures, and must ensure that the code is broken only in accordance with the protocol. The investigator must promptly document and explain to the Sponsor should the identity of the investigational product be revealed (whether accidentally or due to a serious adverse event). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ACTUAL name: Humira® (adalimumab) AC Pen [Reference Product] name: Adalimumab Richmond [Test Product] measure: Peak Serum Concentration of adalimumab (Cmax) measure: Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t) measure: Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞) measure: Number of samples with positive Anti-adalimumab serum antibodies measure: Adverse Events measure: Number of positive Anti-adalimumab serum samples with neutralizing capacity sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: FP Clinical Pharma S.R.L. city: Buenos Aires zip: C1425BAA country: Argentina lat: -34.61315 lon: -58.37723 hasResults: False
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<|newrecord|> nctId: NCT06291935 id: VG901-2021 A id: EU CT: 2023-504383-42-00 type: OTHER domain: EMA briefTitle: Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene overallStatus: RECRUITING date: 2023-09-01 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: ViGeneron GmbH class: INDUSTRY briefSummary: The goal of this phase 1 clinical trial is to learn about the safety and efficacy of a gene therapy, VG901, in patients with a rare disorder of the eye called Retinitis Pigmentosa. The main questions the study aims to answer are:
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* What is the best tolerated dose and are there any side effects, in particular any inflammatory reactions post drug administration?
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* Are there any early signs of efficacy on visual function?
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Participants will be administered a single intravitreal dose of VG901 into the most affected eye through a syringe and followed up for a year to monitor safety and efficacy. There will be two cohorts of participants in this study. Study Cohort 1 will receive the low dose and Study Cohort 2 will receive the high dose as specified in the Protocol. conditions: Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: VG901 measure: Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Physical Examination measure: Pulse rate measure: Blood pressure measure: Body temperature measure: Respiratory rate measure: Slit lamp examination measure: Fundus biomicroscopy measure: Optical coherence tomography (OCT) measure: Fundus autofluorescence measure: Tonometry measure: Adeno-associated virus (AAV) spread measure: Immunopathology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Ophthalmology, University of Tuebingen status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Andrea Rindtorff role: CONTACT lat: 48.52266 lon: 9.05222 hasResults: False
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<|newrecord|> nctId: NCT06291922 id: 853181 id: R01HL166621 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL166621 briefTitle: Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation acronym: MOVE-LVAD II overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-06 date: 2028-06 date: 2024-03-04 date: 2024-04-16 name: University of Pennsylvania class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Exercise Intervention name: Usual Care measure: Effects of exercise intervention on physical activity and capacity (step count) measure: Effects of exercise intervention on physical activity and capacity (distance) measure: Effects of exercise intervention on frailty and muscle mass (frailty status) measure: Effects of exercise intervention on frailty and muscle mass (muscle quantity) measure: Effects of exercise intervention on quality of life measure: Cost-effectiveness of the exercise intervention vs. usual care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291909 id: 205989 briefTitle: Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia overallStatus: RECRUITING date: 2024-04-03 date: 2026-12 date: 2027-01 date: 2024-03-04 date: 2024-03-29 name: University of South Australia class: OTHER name: Flinders University briefSummary: This is a randomised controlled study aiming to evaluate the implementation of a website ('Small Steps') to support the modification of participants' time-use behaviour to reduce the risk factors for dementia. 'Small Steps' website provides the tools for this with a visual representation of the participant's current use of time and allowing manipulation to demonstrate how small lifestyle changes may improve and meet sleep and physical activity needs. Participants will be assisted to make changes to current behaviours with the aim to reduce the time they spend sitting (sedentary behaviour), increase physical activity, and improve sleep duration and quality.
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Participants (aged 65 or older) will be randomly allocated to one of two groups, the 'Extended Program' (intervention) group or the 'Condensed Program' (control) group.
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There are 3 phases (Introductory, Maintenance and Follow-Up; each 12-weeks long) to this program and in total the program is 36-weeks long. Participants will use a tailored website to help support them in making progressive changes over the first 12 weeks. They will then try to maintain these behaviour changes for as long as possible. There will be in-person health testing during each phase and information about sleep habits, sleep quality, and motivation will be assessed using online surveys. Physical activity levels and sleep duration will also be assessed. conditions: Dementia conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Small Steps Program name: Comparator Program measure: Number of participant logins onto the "Small Steps" website measure: Number of participant check-ins on the "Small Steps" dashboard measure: Number of participant behavioural change choices on the "Small Steps" website during the Introduction Phase. The greater number of choices indicates a greater engagement with the intervention and use of the website. measure: Time participants spent on the "Small Steps" website measure: Duration of each participant behavioural change choice during the Introductory Phase measure: Holden's Simplified System Usability Scale measure: Health Care Climate Questionnaire measure: Behavioural Automaticity Questionnaire measure: (Behavioural Regulation in Exercise Questionnaire measure: Self-efficacy and Intention Questionnaire measure: Perceived Competence Scale measure: Exit interview measure: Daily activity measure: Sleep quality measure: Sleep Hygiene measure: Sleep quantity measure: Addenbrooke's Cognitive Exam III measure: Trail Making Test measure: Digit Span Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of South Australia status: RECRUITING city: Adelaide state: South Australia zip: 5001 country: Australia name: Catherine Yandell, PhD role: CONTACT phone: +61 8 83022109 email: catherine.yandell@unisa.edu.au name: Emma Waters, BSc(Hon) role: CONTACT name: Ashleigh Smith, PhD role: PRINCIPAL_INVESTIGATOR name: Maddison Mellow, PhD role: SUB_INVESTIGATOR name: Dorothea Dumuid, PhD role: SUB_INVESTIGATOR name: Tyman Stanford, PhD role: SUB_INVESTIGATOR name: Timothy Olds, PhD role: SUB_INVESTIGATOR name: Hannah Keage, PhD role: SUB_INVESTIGATOR name: Ross Smith, PhD role: SUB_INVESTIGATOR name: Alison Coates, PhD role: SUB_INVESTIGATOR name: Michelle Rogers, PhD role: SUB_INVESTIGATOR name: Catherine Yandell, PhD role: SUB_INVESTIGATOR name: Emma Waters, BSc(Hon) role: SUB_INVESTIGATOR name: Kate Laver, PhD role: SUB_INVESTIGATOR name: Alexander Wade, PhD role: SUB_INVESTIGATOR lat: -34.92866 lon: 138.59863 hasResults: False
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<|newrecord|> nctId: NCT06291896 id: UBT 2023-01 briefTitle: A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection overallStatus: RECRUITING date: 2024-03-15 date: 2026-02-15 date: 2026-12-15 date: 2024-03-04 date: 2024-03-08 name: Umbria Bioengineering Technologies class: INDUSTRY name: Toscana Life Sciences Sviluppo s.r.l. name: London South Bank University name: ELAROS 24/7 Limited (UK) name: Servicio De Salud De Castilla La Mancha (Spain) name: IMT School for Advanced Studies Lucca name: EVITA - Cancro Hereditário (Portugal) briefSummary: This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs. conditions: Women's Health: Neoplasm of Breast studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinical Investigation with class IIa medical device primaryPurpose: SCREENING masking: NONE count: 10000 type: ESTIMATED name: MammoWave measure: MammoWave® sensitivity measure: MammoWave® specificity measure: Detection rates by type of lesion measure: Recall rate measure: Positive-predictive value measure: Program screening rate measure: BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density measure: MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study measure: Agreement between different evaluator (i.e. local versus central) measure: Volunteers' satisfaction questionnaire sex: FEMALE minimumAge: 45 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Giovanni Battista - USL Umbria 2 status: NOT_YET_RECRUITING city: Foligno state: Perugia zip: 06034 country: Italy name: Riccardo Loretoni role: CONTACT email: riccardo.loretoni@uslumbria2.it name: Riccardo Loretoni role: PRINCIPAL_INVESTIGATOR lat: 42.95488 lon: 12.70268 facility: IRCCS Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Massimo Calabrese role: CONTACT email: massimo.calabrese@hsanmartino.it name: Massimo Calabrese role: PRINCIPAL_INVESTIGATOR name: Alberto Stefano Tagliafico role: SUB_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Pomeranian Medical University Hospital status: NOT_YET_RECRUITING city: Szczecin country: Poland name: Jan Lubinsky role: CONTACT email: jan.lubinski@pum.edu.pl name: Jan Lubinsky role: PRINCIPAL_INVESTIGATOR lat: 53.42894 lon: 14.55302 facility: Champalimaud Foundation status: NOT_YET_RECRUITING city: Lisboa country: Portugal name: Filipa Lourenço Cardoso role: CONTACT email: filipa.cardoso@research.fchampalimaud.org name: Celeste Alves role: PRINCIPAL_INVESTIGATOR name: Maria Antónia Vasconcelos role: SUB_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Clínica Dr. Passos Ângelo in Lisbon status: NOT_YET_RECRUITING city: Lisboa country: Portugal name: Ângelo Passos role: CONTACT email: epassosangelo@gmail.com name: Ângelo Passos role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Hospital Universitario Reina Sofía- Córdoba status: NOT_YET_RECRUITING city: Córdoba country: Spain name: Marina Álvarez Benito role: CONTACT email: marinaalvarezbenito@telefonica.net name: Marina Álvarez Benito role: PRINCIPAL_INVESTIGATOR lat: 37.89155 lon: -4.77275 facility: Hospital General Universitario Morales Meseguer status: NOT_YET_RECRUITING city: Murcia country: Spain name: María Martínez Gálvez role: CONTACT email: martinezgalvez@gmail.com name: María Martínez Gálvez role: PRINCIPAL_INVESTIGATOR name: Este Correo role: SUB_INVESTIGATOR lat: 37.98704 lon: -1.13004 facility: Complejo Hospitalario Universitario de Toledo status: NOT_YET_RECRUITING city: Toledo country: Spain name: Daniel Alvarez Sánchez-Bayuela role: CONTACT email: danialsanba@gmail.com name: Cristina Romero Castellano role: PRINCIPAL_INVESTIGATOR lat: 39.8581 lon: -4.02263 facility: Diagnostic and Interventional Radiology, University Hospital Zurich status: NOT_YET_RECRUITING city: Zürich country: Switzerland name: Thomas Frauenfelder role: CONTACT email: thomas.frauenfelder@usz.ch name: Thomas Frauenfelder role: PRINCIPAL_INVESTIGATOR name: Jann Wieler role: SUB_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06291883 id: CHUH112-REC2-008 briefTitle: Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection. overallStatus: COMPLETED date: 2023-02-09 date: 2023-04-18 date: 2024-02-08 date: 2024-03-04 date: 2024-03-06 name: Sheng-Teng Huang class: OTHER briefSummary: These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19. conditions: Coronavirus Disease 2019 conditions: Severe Acute Respiratory Syndrome Coronavirus 2 Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 26 type: ACTUAL name: Kang Guan Recipe (Treat) name: Kang Guan Recipe (Placebo) measure: Serum Infection rate of pseudocells sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: China Medical University Hospital city: Taichung state: North District zip: 404 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06291870 id: F4396-P id: IRB-22-01-4294 type: OTHER domain: John D. Dingell VA Medical Center briefTitle: Predictors of Post-COVID Clinical and Cognitive Consequences acronym: SCLC overallStatus: RECRUITING date: 2023-01-19 date: 2025-07-30 date: 2025-12-30 date: 2024-03-04 date: 2024-04-01 name: VA Office of Research and Development class: FED name: John D. Dingell VA Medical Center briefSummary: The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function. conditions: Post Acute Sequelae of SARS CoV 2 Infection conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Neurocognitive function Trails A and Trails B measure: Neurocognitive function PASAT measure: Neurocognitive function Stroop color-word interference measure: Neurocognitive function DIGIT measure: Neurocognitive function WASI measure: Neurocognitive function WMS measure: Neurocognitive function PVT measure: Neurocognitive function HVLT-R measure: Sleepiness ESS measure: Sleep quality PSQI measure: Quality of life SF-36v2 measure: Quality of life FOSQ measure: Quality of life SGRQ measure: Fatigue Severity measure: PROMISE Sleep Disturbance measure: Horne and Osteberg Morningness/Eveningness Questionnaire measure: Mini Mental State Examination (MMSE) measure: Borg Scale measure: Dyspnea: Six-minute walk test (6MWT) distance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John D. Dingell VA Medical Center, Detroit, MI status: RECRUITING city: Detroit state: Michigan zip: 48201-1916 country: United States name: Ruchi Rastogi, MS role: CONTACT phone: 313-576-4464 email: ruchi.rastogi@va.gov name: Susmita Chowdhuri, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False
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<|newrecord|> nctId: NCT06291857 id: CIC-E-301 briefTitle: A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2025-03-15 date: 2025-04-09 date: 2024-03-04 date: 2024-03-20 name: Novavax class: INDUSTRY briefSummary: The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant. conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 4000 type: ESTIMATED name: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant name: Novavax COVID-19 Vaccine name: Comparator Influenza Vaccine - Fluarix name: Comparator Influenza Vaccine -Fluarix High Dose name: Placebo 0.9% sodium chloride for injection measure: Safety- Solicited AEs over 7 days post-vaccination, For both local injection site symptoms/signs and systemic symptoms/signs measure: Safety-Unsolicited AEs over 21 days post-vaccination and medically attended adverse events (MAAEs). measure: Safety-Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis) over 6 months measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as SCR measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMT measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMFR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as SCR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMTR sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291844 id: Cohort-Mata-2023-1 briefTitle: Ocular Trauma and COVID-19 in Indonesia overallStatus: COMPLETED date: 2021-01-01 date: 2022-03-31 date: 2023-06-01 date: 2024-03-04 date: 2024-03-04 name: Prof. R. D. Kandou General Hospital class: OTHER briefSummary: Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered. conditions: Ophthalmological Disorder conditions: Ocular Injury conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13 type: ACTUAL measure: Ocular Trauma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, Prof. R. D. Kandou General Hospital - Faculty of Medicine, Sam Ratulangi University city: Manado state: North Sulawesi country: Indonesia lat: 1.48218 lon: 124.84892 hasResults: False
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<|newrecord|> nctId: NCT06291831 id: C4671050 briefTitle: A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-13 date: 2024-05-13 date: 2024-05-13 date: 2024-03-04 date: 2024-04-09 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to collect information on the:
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* general information of a group of people such as their age, sex
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* clinical information of the patients such as any other illness before having COVID 19.
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* the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations
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* adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.
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This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.
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This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.
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The study will include patient information of those who:
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* had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.
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* are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: nirmatrelvir, ritonavir name: Controls measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Age measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Gender measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Ethnicity measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Education measure: Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Employment status measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Height measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Weight measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Body Mass Index (BMI) measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Smoking status measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Pre-existing Comorbidities measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Concomitant medications for comorbidities at index date measure: Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Medications used to treat COVID-19 measure: Assessment of all Participants HRU: Inpatient setting measure: Assessment of all Participants HRU sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Gulf FZ city: Busaiteen country: Bahrain hasResults: False
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<|newrecord|> nctId: NCT06291818 id: 2023-0917 briefTitle: Self-Adhering Magnetic Device to Treat Corneal Exposure overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-04-01 date: 2024-03-04 date: 2024-03-04 name: University of Illinois at Chicago class: OTHER briefSummary: Paralytic lagophthalmos can be difficult to treat and manage. It has a host of causes and effects, one of which (for the latter) is exposure keratopathy. Untreated, this can lead to corneal ulceration, inflammation, and potentially blindness. Despite a variety of attempts at treating this complex condition, none have satisfactorily reduced complications ranging from ease of use to aesthetics. With improvement in magnetic technology, however, that may change. Barmettler et al (2014) have demonstrated preliminary success of externally affixed magnets in closing both model and patient eyelids. As such, we hypothesize that magnetic devices can be used to treat corneal exposure by controlling eyelid position. conditions: Paralytic Lagophthalmos conditions: Corneal Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: temporary magnetic system for tarsorrhaphy (MST) primaryPurpose: OTHER masking: NONE count: 25 type: ESTIMATED name: temporary magnetic system for tarsorrhaphy (MST) measure: Number of participants with success of a temporary magnetic system for tarsorrhaphy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois - Specialty Care Building city: Chicago state: Illinois zip: 60612 country: United States name: Pete Setabutr, MD role: CONTACT phone: 312-996-9120 email: psetabut@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06291805 id: 1-10-72-189-23 briefTitle: Phenotyping and Characterization of wtATTR-CM (TRACE 1) overallStatus: RECRUITING date: 2024-02-20 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: Steen Hvitfeldt Poulsen class: OTHER name: Novo Nordisk A/S briefSummary: Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity. conditions: Transthyretin Amyloidosis conditions: Transthyretin Amyloid Cardiomyopathy conditions: Wild-Type Transthyretin-Related (ATTR)Amyloidosis conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED measure: Investigation of cardiac amyloidosis severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. measure: Investigation of the relations between cardiac amyloid severity and patient quality of life in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. measure: Assessment of transthyretin and pathogenic fragments and relation to cardiac amyloid severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy measure: Validation of a new amyloid specific questionnaire (ATTR-QoL) in comparison with Kansas City Cardiomyopathy Questionnaire (KCCQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital status: RECRUITING city: Aarhus state: Arrhus N zip: 8200 country: Denmark name: Sie Kronborg Fensman role: CONTACT phone: +45 30 48 88 85 email: siefensman@gmail.com lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06291792 id: FTR001 briefTitle: Otago Exercise Program Applied By Telerehabilitation acronym: OEPABT overallStatus: RECRUITING date: 2023-11-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-04 date: 2024-03-04 name: Sinop University class: OTHER briefSummary: The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging.
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45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p\<0.05 level in the study. conditions: Older People--Abuse of conditions: Falling conditions: Balance; Distorted studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: telerehabilitation otago exercise program name: face to face otago exercise program measure: Numerical Pain Scale measure: Walking Speed measure: lower extremity muscle strength measure: Fall effectiveness scale measure: Beck anxiety scale measure: Tinetti balance and walking test measure: World Health Organization Quality of Life Scale: sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: Bahçeşehir University research application center status: RECRUITING city: Istanbul country: Turkey name: Sefa Haktan Hatık, PhD role: CONTACT email: haktanhtk@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06291779 id: SNUBH-GS- HBP5 id: E-2211-792-350 (local IRB) type: OTHER domain: Seoul National University Bundang Hospital briefTitle: Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine overallStatus: RECRUITING date: 2022-11-30 date: 2024-02-26 date: 2024-05-31 date: 2024-03-04 date: 2024-03-04 name: Ho-Seong Han class: OTHER name: Seoul National University Bundang Hospital briefSummary: * This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.
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* It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population. conditions: Pancreas Cancer conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio measure: Urine sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ho-Seong Han status: RECRUITING city: Seongnam state: Gyeonggi-do country: Korea, Republic of lat: 37.43861 lon: 127.13778 hasResults: False
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<|newrecord|> nctId: NCT06291766 id: 2022-05498-01 briefTitle: Gestational Diabetes After Gastric Bypass Surgery overallStatus: RECRUITING date: 2024-01-01 date: 2028-12 date: 2035-12 date: 2024-03-04 date: 2024-03-04 name: Region Skane class: OTHER briefSummary: The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.
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The main question it aims to answer is:
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How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.
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Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups. conditions: Diabetes, Gestational conditions: Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium conditions: Pregnancy in Diabetic conditions: Blood Glucose Self Monitoring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: FreeStyle Libre 2, continous glucose monitoring measure: Adverse Pregnancy Outcome measure: Glucose values measure: Glucose values measure: Glucose values measure: Glucose values measure: Glucose values measure: Pharmacological treatment measure: Pharmacological treatment measure: Pharmacological treatment measure: Pharmacological treatment measure: Birthweight measure: Week of delivery sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Region Skane status: RECRUITING city: Lund zip: 221 85 country: Sweden name: Ulrika Moll, MD, PhD role: CONTACT lat: 55.70584 lon: 13.19321 hasResults: False
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<|newrecord|> nctId: NCT06291753 id: SL-B2023-478-01 briefTitle: Characteristics and Tumor Staging Proposal for Primary Malignant Melanoma of the Esophagus overallStatus: COMPLETED date: 2023-09-22 date: 2024-02-18 date: 2024-02-18 date: 2024-03-04 date: 2024-03-04 name: Sun Yat-sen University class: OTHER briefSummary: Background: Primary malignant melanoma of the esophagus (PMME) is a malignant tumor originating from esophageal melanocytes with a poor prognosis. No international clinical guidelines or tumor staging systems have been proposed for PMME. This study aimed to analyze the clinical characteristics and treatment outcomes of patients with PMME and propose a tumor staging system in PMME.
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Materials and Methods: The clinical characteristics of 25 patients with PMME at our cancer center were summarized, and 21 patients were enrolled in a pooled analysis with 162 cases (extracted from 74 eligible articles in PubMed) for further survival analysis and proposal of PMME tumor staging. conditions: Primary Malignant Melanoma of the Esophagus studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: RETROSPECTIVE count: 25 type: ACTUAL measure: Overall Survival(OS) measure: Disease-free survival (DFS) sex: ALL minimumAge: 23 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qianwen Liu city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06291740 id: MTU-EC-EM-2-008/67 id: Faculty of Medicine type: OTHER domain: Thammasat University, Thailand briefTitle: Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-03-04 date: 2024-03-04 name: Thammasat University class: OTHER briefSummary: The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented. conditions: Asthma Exacerbation conditions: Emergency Department conditions: Nebulization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial (RCT) primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: continuous nebulization name: Intermittent nebulization measure: Length of ED stay measure: pulmonary function test measure: Hospital admission measure: ED revisit within 48 hours sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291727 id: Prisma Upstate briefTitle: Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA overallStatus: RECRUITING date: 2024-02-16 date: 2025-07-01 date: 2025-07-01 date: 2024-03-04 date: 2024-03-04 name: Prisma Health-Upstate class: OTHER briefSummary: This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
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Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization. conditions: Anesthesia, Spinal conditions: Arthroplasty, Replacement, Knee studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized 1:1 to one of two groups; one receiving Mepivacaine spinal anesthesia and the other receiving Bupivacaine spinal anesthesia for total knee arthroplasty (TKA). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigators and participants will not know which anesthetic agent they receive. Anesthesia providers will be aware in order to provide correct randomization. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 138 type: ESTIMATED name: Mepivacaine name: Bupivacaine measure: Same day discharge rate measure: Post-operative pain score as assessed by numeric rating scale (NRS) measure: Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively measure: Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity measure: Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively measure: Pain Medications as evaluated by medical morphine equivalents measure: Patient satisfaction levels as assessed by a 5-item Likert response scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Health Patewood Hospital status: RECRUITING city: Greenville state: South Carolina zip: 29615 country: United States name: Kyle Adams role: CONTACT phone: 864-455-3449 email: Kyle.Adams@prismahealth.org lat: 34.85262 lon: -82.39401 hasResults: False
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<|newrecord|> nctId: NCT06291714 id: Clearsight briefTitle: Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension acronym: Clearsight overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2026-03-31 date: 2024-03-04 date: 2024-03-15 name: University of Giessen class: OTHER name: Edwards Lifesciences briefSummary: In order to reduce the incidence of IOH, various goal-directed therapy (GDT) protocols have already been introduced with success regarding the reduction of postoperative AKI and MINS. However, these studies used an invasive hemodynamic monitoring which offered a continuous surveillance of the blood pressure. In contrast, standard non-invasive blood pressure monitoring results in a blind gap between two measurements (mostly three or five minutes). In order to address this limitation, different continuous non-invasive blood pressure monitoring devices have been introduced. The next evolutional step of non-invasive cardiac output monitoring was to prevent IOH before their onset by using the Hypotension Prediction Index (HPI). Based on the Edward ́s monitoring platform, HPI is a monitoring tool which aims to predict IOH (defined as MAP\<65 mmHg for at least one minute) up to 15 min before its onset. The underlying machine learning based algorithm uses analyses features from the pressure waveform and was first calculated from a large retrospective data set of surgical patients and subsequently validated in a prospective cohort. In this study HPI showed a sensitivity of 88% and specificity of 87% for predicting IOH 15 min before its onset. Since then, own and studies of other working groups confirmed the effective prevention of IOH by the use of HPI-based GDT. Until today the arterial waveform analysis was dependent on invasive arterial measurement but since Edwards Lifesciences already promoted the start of the HPI on the ClearSight platform a non-invasive measurement will soon be possible.
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Further, until now it has not yet been proven that the perioperative use of a continuous non-invasive blood pressure monitoring has a beneficial effect on the patient´s outcome.
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Study objectives The aim of the study is to investigate whether a hemodynamic protocol based on continuous non-invasive cardiac output monitoring (ClearSight system) compared to standard care can reduce the incidence of IOH, postoperative AKI, and MINS in patients undergoing major trauma and orthopedic surgery. conditions: Intraoperative Hypotension conditions: Acute Kidney Injury conditions: Myocardial Injury After Non-cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Management of interventional group patients Prior to the surgery the rest cardiac index and contractility (dp/dt) must be quantified. For this purpose, the cardiac index will be measured in the preoperative night by applicating the HPI ClearSight system through a study team member. If the rest cardiac index is not available throughout the night because the patient´s sleep is altered by the measurements, the awake cardiac index will be quantified until the monitoring is stopped for the night sleep of the patient. This mean baseline measurements (CI and dp/dt) will then be the target cardiac index throughout the study algorithm (figure 1). In case no sleep measurement was achievable, the awake measurement will be accounted as baseline value. The perioperative study intervention period starts with the beginning of anesthesia and ends at the end of surgery. Intraoperative mean arterial pressure will be maintained at least at 65 mmHg and cardiac index and dp/dt will be individually primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: All patients are connected to the Clearsight device but the interface is masked in the control group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: GDT-based hemodynamic management based on Clearsight device measure: Change of the frequency of intraoperative hypotension measure: Change of the absolute duration of of intraoperative hypotension measure: Change of the relative duration of intraoperative hypotension measure: AKI measure: MINS sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291701 id: ODUSBFFTR-ELIFAYGUNPOLAT-002 briefTitle: The Relationship Between Scapular Endurance, Core Endurance, and Functional Performance in Adolescent Tennis Players overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-15 date: 2024-04-01 date: 2024-04-15 date: 2024-03-04 date: 2024-04-04 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: This study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. The hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. Establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players. conditions: Athletic Injuries conditions: Sports Physical Therapy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 35 type: ESTIMATED name: Assessment of scapular endurance name: Prone Bridge Test name: Side Bridge Test name: Closed Kinetic Chain Upper Extremity Stability Test name: Seated Medicine Ball Throw Test measure: Prone Bridge Test measure: Side Bridge Test measure: Scapular Endurance Values measure: Closed Kinetic Chain Upper Extremity Stability Test measure: Seated Medicine Ball Throw Test sex: ALL minimumAge: 11 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ordu University city: Ordu zip: 52200 country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False
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<|newrecord|> nctId: NCT06291688 id: 202312004RIND briefTitle: Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability overallStatus: RECRUITING date: 2024-01-26 date: 2025-12-31 date: 2026-01-31 date: 2024-03-04 date: 2024-03-04 name: National Taiwan University Hospital class: OTHER briefSummary: The goal of this clinical interventional study is to compare the efficacy of mobile healthcare education in two ways (game-based or text-based) to improve cutaneous self-care capability in cancer patients receiving EGFR-based target therapy. The main questions it aims to answer are:
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Impact of different mobile healthcare education ways on cutaneous self-care capability of patients Impact of different mobile healthcare education ways on learning motivation of patients towards cutaneous self-care knowledge and skills
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Participants will be randomly divided into two groups. Both groups will download a healthcare education application on their phone. One group will accept the education about the knowledge and self-care skills of cutaneous adverse drug reaction by playing game. In contrast, the other group will accept the same education content by reading text on the phone. Subjects will be asked to use the application at home for two weeks after giving consent to participate this study, and then completed questionnaire three times during study period. The timepoints of completing questionnaire are listed following:
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Baseline / pre-intervention test (after signing informed consent form, D1) First post-intervention test (after finishing intervention, D15) Second post-intervention test (D30) Researchers will compare game group and text group to see if game group has better performance on cutaneous self-care capability and learning motivation. conditions: EGFR Gene Mutation conditions: Drug-Related Side Effects and Adverse Reactions conditions: Cancer, Treatment-Related conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: Mobile healthcare education game name: Mobile healthcare education application measure: Change from baseline in the score of cutaneous adverse drug reaction (CADR) knowledge on researcher-designed questionnaire at Day 15 and Day 30. measure: Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15 measure: Change from baseline in the score of the quality of life on DLQI questionnaire at Day 15 and Day 30 measure: Investigate the user-experience of the mobile healthcare education APP by researcher-designed questionnaire at Day 15. measure: Change from baseline in the score of the self-care measurement adherence on researcher-designed questionnaire at Day 15 and Day30. measure: The correlation among APP usability, learning motivation and self-care capability. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100225 country: Taiwan name: XinYi Lin, Bs role: CONTACT phone: +886988619601 email: r11426019@ntu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06291675 id: 2083/2022 briefTitle: Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content overallStatus: RECRUITING date: 2023-03-03 date: 2026-03-03 date: 2033-03-03 date: 2024-03-04 date: 2024-03-04 name: Medical University of Vienna class: OTHER briefSummary: Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce.
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Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment.
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Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment.
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Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires.
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Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years.
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Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study. conditions: Gender Dysphoria conditions: Hormone Therapy Induced Morphologic Change studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: gender-affirming hormone therapy measure: Myocardial mass measure: Cardiac function - LVEF measure: cardiac function - cardiac output index measure: Organ lipid content measure: Subcutaneous to visceral fat ratio sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chiari Stoffwechselambulanz, Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Carola Deischinger, MD PhD role: CONTACT phone: +43140400 phoneExt: 20690 email: carola.deischinger@meduniwien.ac.at name: Alexandra Kautzky-Willer, Prof, MD role: CONTACT email: alexandra.kautzky-willer@meduniwien.ac.at name: Alexandra Kautzky-Willer, Prof, MD role: PRINCIPAL_INVESTIGATOR name: Carola Deischinger, MD PhD role: SUB_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06291662 id: PRECISE_IC briefTitle: Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Kathleen McGreevy class: OTHER briefSummary: Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. conditions: Sarcoma conditions: Intracranial Neoplasm conditions: Pelvic Bone Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Oncologic patients primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: 3D printer applications measure: 3D model feasibility for pre-surgical making decisions measure: Surgical time measure: Device feasibility sex: ALL minimumAge: 7 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria Careggi (AOUC) status: ACTIVE_NOT_RECRUITING city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Federico Mussa, MD role: CONTACT email: federico.mussa@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Senese (AOUS) status: ACTIVE_NOT_RECRUITING city: Siena country: Italy lat: 43.31822 lon: 11.33064 hasResults: False
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<|newrecord|> nctId: NCT06291649 id: AMIETOX briefTitle: Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age overallStatus: RECRUITING date: 2023-04-05 date: 2033-04-05 date: 2033-08-05 date: 2024-03-04 date: 2024-03-04 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.
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The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.
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Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room). conditions: Acute Intoxication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Determination of Incidence of intoxication in paediatric children measure: Determination of Prevalence of intoxication in paediatric children sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: Ospedale Santa Maria Annunziata status: RECRUITING city: Bagno A Ripoli state: Firenze zip: 50139 country: Italy name: Anna Chiara Azzali role: CONTACT phone: 055 69361 email: annachiara.azzali@uslcentro.toscana.it lat: 43.75115 lon: 11.32252 facility: Ospedale Del Mugello status: RECRUITING city: Borgo San Lorenzo state: Firenze zip: 50139 country: Italy name: Rosalia Emidia Di Silvio role: CONTACT email: rosaliaemidia.disilvio@uslcentro.toscana.it lat: 43.95548 lon: 11.38561 facility: Ospedale G B Morgagni status: RECRUITING city: Forlì state: Forlì-Cesena country: Italy name: Melodie Aricò role: CONTACT email: melodieolivialoredanarosa.arico@auslromagna.it lat: 44.22177 lon: 12.04144 facility: Mater Salutis status: RECRUITING city: Legnago state: Verona country: Italy name: Anna Maria Colombaria role: CONTACT email: annamaria.colombari@aulss9.veneto.it lat: 45.19365 lon: 11.30227 facility: Ospedale Maggiore status: RECRUITING city: Bologna country: Italy name: Chiara Ghizzi role: CONTACT email: chiara.ghizzi@ausl.bologna.it lat: 44.49381 lon: 11.33875 facility: Ospedale Centrale Bolzano status: RECRUITING city: Bolzano country: Italy name: Ylenia Girtler role: CONTACT email: ylenia.girtler@sabes.it lat: 46.49067 lon: 11.33982 facility: Ospedale Brotzu status: RECRUITING city: Cagliari country: Italy name: Gabriella Cherchi role: CONTACT email: gacherchi@gmail.com lat: 39.23054 lon: 9.11917 facility: Ospedale San Giuseppe status: RECRUITING city: Empoli zip: 50053 country: Italy name: Antonino Francesco Capizzi role: CONTACT email: antoninofrancesco.capizzi@uslcentro.toscana.it lat: 43.71795 lon: 10.94758 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence zip: 50139 country: Italy name: Marco De Luca role: CONTACT phone: 0555662051 email: marco.deluca@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Misericordia status: RECRUITING city: Grosseto zip: 58100 country: Italy name: Francesca Bonsignori role: CONTACT email: francesca.bonsignori@uslsudest.toscana.it lat: 42.76296 lon: 11.10941 facility: Policlinico Messina status: RECRUITING city: Messina country: Italy name: Laura Colavita role: CONTACT email: lauracol85@gmail.com lat: 38.19394 lon: 15.55256 facility: Ospedale San Francesco status: RECRUITING city: Nuoro country: Italy name: Antonio Cualbu role: CONTACT email: antonio.cualbu@atssardegna.it lat: 40.31991 lon: 9.32568 facility: Ao Padova status: RECRUITING city: Padova country: Italy name: Francesco Corazza role: CONTACT email: francesco.corazza@aopd.veneto.it lat: 45.40797 lon: 11.88586 facility: Nuovo Ospedale Dei Bambini status: RECRUITING city: Parma country: Italy name: Monica Rubini role: CONTACT email: rubinim@ao.pr.it lat: 44.79935 lon: 10.32618 facility: Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Thomas Foiadelli role: CONTACT email: thomas.foiadelli@gmail.com lat: 45.19205 lon: 9.15917 facility: Policlinico Pescara status: RECRUITING city: Pescara country: Italy name: Giorgia Carlone role: CONTACT email: giorgia.carlone@asl.pe.it lat: 42.4584 lon: 14.20283 facility: Ospedale Santa Chiara - Cisanello status: RECRUITING city: Pisa country: Italy name: Alessandro Orsini role: CONTACT email: aorsini.md@gmail.com lat: 43.70853 lon: 10.4036 facility: Ospedale San Jacopo status: RECRUITING city: Pistoia zip: 51100 country: Italy name: Francesca Mangiantini role: CONTACT email: francesca.mangiantini@usl.toscana.it lat: 43.93064 lon: 10.92365 facility: Ospedale Civile Santa Maria Degli Angel status: RECRUITING city: Pordenone country: Italy name: Daniele Santori role: CONTACT email: daniele.santori@asfo.sanita.fvg.it lat: 45.95689 lon: 12.66051 facility: Ospedale Santo Stefano status: RECRUITING city: Prato zip: 59100 country: Italy name: Francesca Grisolia role: CONTACT email: francesca.grisolia@uslcenntro.toscana.it lat: 43.8805 lon: 11.09699 facility: Ospedale Infermi status: RECRUITING city: Rimini country: Italy name: Gianluca Vergine role: CONTACT email: gianluca.vergine@auslromagna.it lat: 44.05755 lon: 12.56528 facility: CAV Gemelli status: RECRUITING city: Roma country: Italy name: Maurizio Paolo Soave role: CONTACT email: centro.antiveleni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 facility: Policlinico Gemelli status: RECRUITING city: Roma country: Italy name: Antonio Gatto role: CONTACT email: antonio.gatto@policlinicogemelli.it lat: 41.89193 lon: 12.51133 facility: Ospedale Regina Margherita status: RECRUITING city: Torino country: Italy name: Claudia Bondone role: CONTACT email: claudiabondone@virgilio.it lat: 45.07049 lon: 7.68682 facility: Santa Chiara status: RECRUITING city: Trento country: Italy name: Stefania Ielo role: CONTACT email: stefania.ielo@apss.tn.it lat: 46.06787 lon: 11.12108 facility: Ulss 2 Marca Trevigiana status: RECRUITING city: Treviso country: Italy name: Valentina Brugnarolo role: CONTACT email: valentina.brugnolaro@aulss2.veneto.it lat: 45.66673 lon: 12.2416 facility: Burlo Garofalo status: RECRUITING city: Trieste country: Italy name: Alessandro Amaddeo role: CONTACT email: alessandro.amaddeo@burlo.trieste.it lat: 45.64953 lon: 13.77679 facility: Clinica Pediatrica Udine status: RECRUITING city: Udine country: Italy name: Chiara Pilotto role: CONTACT email: chiara.pilotto@asufc.sanita.fvg.it lat: 46.0693 lon: 13.23715 facility: CAV Veneto status: RECRUITING city: Verona country: Italy name: Giorgio Ricci role: CONTACT email: centroantiveleno@aovr.veneto.it lat: 45.4299 lon: 10.98444 facility: Ospedale Della Donna E Del Bambino status: RECRUITING city: Verona country: Italy name: Pietro Soloni role: CONTACT email: pietro.soloni@aovr.veneto.it lat: 45.4299 lon: 10.98444 facility: Ospedale San Bortolo status: RECRUITING city: Vicenza country: Italy name: Ilaria Tosetto role: CONTACT email: ilaria.tosetto@aulssl8.veneto.it lat: 45.54672 lon: 11.5475 hasResults: False
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<|newrecord|> nctId: NCT06291636 id: R.24.01.2451 briefTitle: Re- Admission Rate Among Survived Patients With Acute Respiratory Failure overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2024-01-20 date: 2024-03-04 date: 2024-03-04 name: Mansoura University class: OTHER briefSummary: Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family conditions: Respiratory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 994 type: ACTUAL measure: Length of hospital and ICU stay and Cause of readmission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tamer Awad Elsayed city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06291623 id: Molecular Analysis briefTitle: Molecular Analysis of Intracanal Microbes After Chemomechanical Procedure and Root Canal Medication: Clinical Study overallStatus: COMPLETED date: 2022-05-03 date: 2023-12-20 date: 2024-01-15 date: 2024-03-04 date: 2024-03-04 name: Mansoura University class: OTHER briefSummary: This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples. conditions: Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ACTUAL name: Glycyrrhizin measure: minimizing of viable bacteria which showed by Real time PCR sex: ALL minimumAge: 19 Years maximumAge: 60 Years stdAges: ADULT facility: Mansoura University city: Mansoura state: Dakahliya zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06291610 id: Aarhus University Hospital briefTitle: Feasibility Testing a Decision-support Intervention for Clinical Trials overallStatus: RECRUITING date: 2024-02-19 date: 2025-12-31 date: 2026-12-31 date: 2024-03-04 date: 2024-03-04 name: University of Aarhus class: OTHER briefSummary: A decision-support intervention are developed for a Danish nationwide randomised controlled trial (RCT) among patients with laryngeal and pharyngeal cancer referred to curative intended radiotherapy. The primary endpoints in this RCT are levels of dysphagia and xerostomia.
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The decision-support intervention consists of three components, including (1) a patient decision aid tailored to clinical trial participation and (2) decision coaching consultations carried out by trained healthcare professionals. Finally, (3) a training program in decision coaching will be an integrated part of the intervention.
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To feasibility test (beta test) the intervention, 60 patient participants will be included, separated into pre- (n=30) and post- (n=30) intervention groups. Pre-intervention to complete the survey based on current clinical practice. Post-intervention to complete the survey following engagement in the decision support intervention.
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A total of 12 physicians will be recruited and trained in decision coaching. To assess the acceptability of the intervention, the physicians will be interviewed. Additionally, they will be asked to audio-record two decision coaching sessions to test the fidelity of the intervention. conditions: Head and Neck Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre- and post-intervention measures in two consecutive groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Patients are recruited anonymous count: 60 type: ESTIMATED name: Clinical trial decision support intervention measure: Decisional conflict scale measure: The decision preparation scale measure: The stages of decision making measure measure: Items on health literacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Anne Kristensen role: CONTACT phone: +4530315605 email: annkrs@rm.dk name: Cai Grau role: CONTACT email: cai.grau@rm.dk lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06291597 id: 22071 briefTitle: Vaping Adverse Lung and Heart Events Cohort acronym: VapALERT overallStatus: RECRUITING date: 2021-10-14 date: 2031-12 date: 2032-06 date: 2024-03-04 date: 2024-03-04 name: Laval University class: OTHER name: Ministere de la Sante et des Services Sociaux briefSummary: This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up. conditions: Vaping conditions: Electronic Cigarette Use studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Vaping measure: Number of participants who vape daily with impaired lung volumes. measure: Number of participants who vape daily with impaired lung diffusion capacity. measure: Number of participants who vape daily with impaired spirometry. measure: Number of participants who vape daily with airway hyperresponsiveness. measure: Number of participants who vape daily with changes in blood cell count. measure: Number of participants who vape daily with changes in sputum cell count. measure: Vaping, tobacco and cannabis smoking habits of participants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IUCPQ-UL status: RECRUITING city: Québec zip: G1V 4G5 country: Canada name: Ariane Lechasseur, PhD role: CONTACT phone: 418-656-8711 phoneExt: 2652 email: ariane.lechasseur@criucpq.ulaval.ca name: Mathieu C Morissette, PhD role: PRINCIPAL_INVESTIGATOR name: Andréanne Côté, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
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<|newrecord|> nctId: NCT06291584 id: P20230001 briefTitle: Effects of Exercises on Functional Capacity overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-01 date: 2024-10-01 date: 2024-03-04 date: 2024-03-08 name: Kırklareli University class: OTHER briefSummary: In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity. conditions: Nicotine Addiction conditions: Respiratory Disease conditions: Sedentary Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study consists of three groups. Groups to be formed: Group 1: face-to-face exercise group; Group 2: Online (Telehealth) Exercise Group; Group 3: Control Group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: First of all, the randomization of exercise groups will be performed according to the closed envelope procedure. The student who selects one of the envelopes with the names of the three groups will be included in the group written in the envelope he selected. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Exercise measure: International Physical Activity Questionnaire - Short Form measure: Six-Minute Walk Test- (6MWT) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kirklareli University status: RECRUITING city: Kırklareli state: Kayalı zip: 39000 country: Turkey name: Fulya DEMIRHAN, Res. Ass. role: CONTACT phone: +90-532-353-2208 email: fulyademirhan@klu.edu.tr lat: 41.73508 lon: 27.22521 hasResults: False
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<|newrecord|> nctId: NCT06291571 id: 324543 briefTitle: Assessment of Microorganisms and Host Response In Liver Diseases acronym: MILD overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2029-02-28 date: 2030-03-01 date: 2024-03-04 date: 2024-03-04 name: University of Aberdeen class: OTHER briefSummary: The normal human gut is home to millions of microbes including bacteria, fungi, and viruses, collectively forming the gut microbiota, which exists in harmony within us. Much research is still required to fully understand the contribution of microbes resident in the large intestine in liver diseases. The liver receives blood from the gut carrying all the necessary nutrients needed for our body but also has to deal with toxins derived from the microbes residing in the intestines. The gut microbiota is altered in liver disease. We still do not know clearly how this change impacts liver function and the health of liver patients. The purpose of our study is to answer this question by assessing the gut microbiota using modern microbiological and molecular methods. By studying the alterations in the gut microbiota in patients with liver disease we can understand how they affect our immune system and metabolism. This will help design novel medicinal products to prevent and treat liver disease. conditions: Gut Microbiome conditions: Liver Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To identify the bacterial, fungal, and virological agents present in patients with liver disease as opposed to controls measure: To assess the host immune response against specific microbes isolated from patients with liver disease and controls measure: To characterise the changes in the liver immune microenvironment by analysing liver biopsies from patients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291558 id: P202200027 briefTitle: Exercise Training for Smoking Students overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-01 date: 2024-10-01 date: 2024-03-04 date: 2024-03-04 name: Kırklareli University class: OTHER briefSummary: Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability. conditions: Nicotine Dependence conditions: Smoking conditions: Physical Inactivity conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The participants will be informed that the study was carried out for scientific purposes and the information will not be shared with third parties. Randomization of exercise groups will be performed according to the closed envelope procedure. The student who selects one of the envelopes with the names of the 3 groups will be included in the group written in the envelope he selected. Information about other groups will not be shared. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Exercise measure: International Physical Activity Questionnaire (Short) measure: Six-Minute Walk Test measure: Scoring the Fagerstrom Test for Nicotine Dependence (FTND) measure: Beck's Depression Inventory (BDI) measure: Lung Function Test sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kirklareli University status: RECRUITING city: Kırklareli state: Kayalı zip: 39000 country: Turkey name: Fulya DEMIRHAN, Res. Ass. role: CONTACT phone: +90-532-353-2208 email: fulyademirhan@klu.edu.tr lat: 41.73508 lon: 27.22521 hasResults: False
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<|newrecord|> nctId: NCT06291545 id: JW-SBC202202 briefTitle: Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-05 name: JW Medical Systems Ltd class: INDUSTRY briefSummary: This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） name: ScoreFlex NC Coronary Dilatation Catheter measure: Rate of successful device usage measure: Rate of success of the surgery measure: Incidence of in-hospital MACE measure: Incidence of PoCE within 30 days after surgery measure: The lumen is obtained immediately sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291532 id: VRRS01 briefTitle: Feasibility and Usability of a Virtual Reality System overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2025-09-30 date: 2025-09-30 date: 2024-03-04 date: 2024-03-04 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. The Virtual Reality Rehabilitation System (VRRS) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. The use of VRRS offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults. conditions: Autism Spectrum Disorder conditions: Intellectual Disability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Rehabilitation with VRRS measure: Usability questionnaire measure: Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time measure: Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: the number of repetitions of the exercises. measure: Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise. sex: ALL minimumAge: 6 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo city: Messina zip: 98124 country: Italy lat: 38.19394 lon: 15.55256 hasResults: False
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<|newrecord|> nctId: NCT06291519 id: SHN50343434 briefTitle: The Effect of Multisensory Stimulus Method on Pain and Physiological Parameters in Infants overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-30 date: 2023-12-30 date: 2024-03-04 date: 2024-03-04 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study aimed to investigate the impact of employing the multi-sensory stimulation technique by both the mother and the nurse on the pain and physiological responses of infants aged 2-6 months during vaccination. The significance of pain experienced during vaccination in children is emphasized, potentially leading to avoidance behaviors toward healthcare services. There is growing evidence supporting the efficacy of non-pharmacological interventions. Multi-sensory stimulation, which integrates various stimuli such as taste, touch, and speech, alleviates infant pain. However, there has been a lack of studies assessing the effectiveness of this approach during vaccination administered by different healthcare providers. Hence, this study sought to explore the effects of multi-sensory stimulation by both mother and nurse applied to pain and physiological parameters. It is anticipated that the findings of this study will contribute to both pain management strategies and healthcare practices. conditions: Multisensory Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled experimental design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 96 type: ACTUAL name: Multi-sensory Stimulation Method-Mother Applying the Method to the Baby name: Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby name: Breastfeeding Applied Group measure: The Effect of Multiple Sensory Stimulus Method measure: Comparison of the group in which the mother applied multiple sensory stimuli and the group in which the nurse applied multiple sensory stimuli sex: ALL minimumAge: 2 Months maximumAge: 6 Months stdAges: CHILD facility: Istanbul University-Cerrahpasa city: Istanbul state: None Selected zip: 34381 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06291506 id: 6270 briefTitle: SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER). acronym: SUPAFER overallStatus: RECRUITING date: 2023-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-03-04 date: 2024-03-04 name: Hospital Universitario La Paz class: OTHER briefSummary: Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.
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Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic. conditions: Persistent and Long Lasting or Chronic Atrial Fibrillation conditions: Atrial Fibrillation Ablation conditions: Linear Left Atrial Ablation conditions: Daily Transtelephonic Electrocardiogram studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Radiofrequency ablation of heart atrial tissue. measure: Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter. measure: Acute intraprocedure efficacy. measure: Complications. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: La Paz University Hospital - IdiPaz status: RECRUITING city: Madrid country: Spain name: José Luis Merino, MD role: CONTACT phone: +34 912071301 email: lapaz@arritmias.net name: Sergio Castrejón Castrejón role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06291493 id: CS-2024-0002 briefTitle: Precision Study Measuring Potassium (K) in Capillary Specimens overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-10 date: 2024-12 date: 2024-03-04 date: 2024-03-22 name: Abbott Point of Care class: INDUSTRY briefSummary: Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer. conditions: Precision of Potassium (K) Test in Capillary Whole Blood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Capillary precision analysis will be performed for Potassium K. primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Fingerstick blood draw measure: Precision for Potassium (K) Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06291480 id: NL78853.058.22 / STRUM briefTitle: Music Therapy After Stroke (Subacute Phase) overallStatus: RECRUITING date: 2023-01-01 date: 2024-08 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Universiteit Leiden class: OTHER name: Amstelring briefSummary: The goal of this longitudinal, single-subject study is to investigate the role of motivation in music therapy for stroke patients within the subacute phase, who experience upper limb and/or attention deficits. The main questions it aims to answer are:
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* Does music therapy increase patient's motivation to rehabilitate?
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* Do increases in motivation correlate with functional improvements, in particular upper limb and/or attention skills?
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Participants will receive up to 9 music therapy sessions within 3-5 weeks, with functional assessments before and after each period. Each participant serves as their own comparison: researchers will compare a period with standard care only (control phase) to a period with music therapy plus standard care (intervention phase), the order of which will be randomized in advance. conditions: Stroke (CVA) or TIA conditions: Stroke/Brain Attack studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Neurologic Music Therapy measure: Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported] measure: Motor Function: Action Research Arm Test (ARAT) measure: Motor Function: Barthel Index (BI) measure: Cognition: Cancellation Wechsler Adult Intelligence Scale (WAIS-IV) measure: Cognition: Color-Word Interference Test, also known as Stroop test measure: Cognition: WAIS IV Digit Span Test - Forward and Backward measure: Cognition: Verbal Fluency Test measure: Cognition: Trail Making Test (TMT) measure: Motivation to engage in musical activities: Barcelona Music Reward Questionnaire (BMRQ) measure: Quality of Life: EuroQol-5 (EQ-5D-5L) measure: Mood: Depression Anxiety Stress Scale-21 (DASS-21) measure: Mood: Visual Analogue Mood Scale (VAMS) measure: Personality Traits: The Big Five Index-Extra Short Form (BFI-2-XS) measure: Optimism: Life Orientation Test- Revised (LOT-R) measure: Brief self-report of therapy expectations and satisfaction with treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leo Polak Rehabilitation centre status: RECRUITING city: Amsterdam state: Nederland zip: 1069BW country: Netherlands name: Theo Dimitriadis, MSc role: CONTACT email: tdimitriadis@amstelring.nl lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06291467 id: RECHMPL23_0121 briefTitle: Plasma Beta-endorphin Levels and Suicidal Behavior acronym: BEST overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Montpellier class: OTHER name: Institut de Génomique Fonctionnelle (IGF) de Montpellier briefSummary: It is an interventional research, monocentric, which involves only minimal risks and constraints.
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Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.
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The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.
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The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA. conditions: Suicide conditions: Depression conditions: Beta Endorphin studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 104 type: ESTIMATED name: Blood samples name: questionnaires measure: Comparison of plasma β-endorphin levels between patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any lifetime history of suicide attempt. measure: - The kinetics of β-endorphin levels between two measurement points (inclusion and D7+/-2 days) in patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any history of suicide attempt. measure: The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS) measure: The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16) measure: To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion, measure: To assess the association between β-endorphin levels and Anhedonia measure: To assess the association between β-endorphin levels and Current psychological and physical pain as well as usual and maximum over the 15 days before inclusion measure: To assess the association between β-endorphin levels and Anxiety, sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University hospital city: Montpellier zip: 34295 country: France name: Jessica DALAUDIERE role: CONTACT email: jessica.dalaudiere@chu-montpellier.fr lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06291454 id: 741100 briefTitle: GCF Levels of Chemokines in Periodontitis overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-01 date: 2023-12-01 date: 2024-03-04 date: 2024-03-08 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.
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